Brian Hagen, managing director of Decision Empowerment Institute, states that to quantify risk using this approach also helps risk managers decide whether to act or not on any particular exposure. He says that, "Once you have the numbers, you can decide how to adjust your mitigation."

In a recent pilot program, a process manufacturing company was ready to cease making one of its products because the supply chain costs were too high. "We used [the DEI approach] as a test case," a company official said, "and after running the calculations for two or three weeks, the data came back that we should continue to manufacture [this product]. We were even able to get hard data on the most economical supply-chain alternatives."

On another client project, the primary risk-management goals identified were to:

1) Being able to run the top risks through a standard model
2) Modeling how they can analyze world events and the resultant broad impact (e.g., tsunami impact)
3) High-level business decision-making to analyze risk
4) Creating a risk analysis center of excellence (COE) organization to define an operational structure
5) Working with operations strategic planning (OSP)

According to Enterey CEO Mike Ferletic, "Establishing tools to analyze spend and resource utilization will not only save significant investment, but will also provide a means to proactively evaluate future changes to production when demand changes," and, he says, "these tools give insight as to how to handle those changes." The result of DEI's approach for quantifying operational and compliance risk and decision-making has resulted in millions of savings to shareholders' bottom lines.

Enterey Life Sciences Consulting, founded in 2002, provides life sciences consulting expertise in both process- and systems-related projects for biotech, medical device, and pharmaceutical clients. Enterey provides solutions ranging from strategic planning to business-integration, and has a proven track record of success supporting both clinical and commercial facility start-ups.